Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: biopsy (Procedure); magnetic resonance imaging (Procedure); radiomammography (Procedure); ultrasound imaging (Procedure); gadopentetate dimeglumine (Radiation); chemotherapy (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Alliance for Clinical Trials in Oncology Official(s) and/or principal investigator(s): Laura J. Esserman, MD, MBA, Study Chair, Affiliation: University of California, San Francisco
Summary
RATIONALE: Comparing results of diagnostic procedures performed before, during, and after
chemotherapy may help doctors predict a patient's response to treatment and help plan the
most effective treatment.
PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women
who are receiving chemotherapy before surgery for locally advanced breast cancer.
Clinical Details
Official title: Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: response
Detailed description:
OBJECTIVES:
Primary
- Support accrual to the ACRIN-6657/CALGB-150012 magnetic resonance imaging (MRI)
correlative science study.
- Determine whether molecular markers, alone or in combination with MRI, at the time of
diagnosis or early in the course of therapy, predict 3-year disease-free survival (DFS)
in women with locally advanced breast cancer who are receiving neoadjuvant
chemotherapy.
- Identify two groups of participants who have statistically different 3-year DFS, based
on 1 or more biomarkers, including MRI.
- Determine whether biomarkers, in combination with MRI, early in the course of
chemotherapy, improve the prediction of 3-year DFS and are at least as good of a
predictor of DFS as residual disease at the time of surgery in these patients.
- Determine whether molecular markers are associated with specific imaging patterns seen
on MRI of these patients.
- Predict response with MRI results and marker data from cell cycle check points,
proliferation, angiogenesis, hormone receptors, and molecular profiles in these
patients.
Secondary
- Determine the molecular predictors of lack of radiologic complete response (CR) in
HER-2/neu negative patients (immunohistochemistry [IHC] score of 0, 1+, 2 and
fluorescence in situ hybridization [FISH] not amplified) after a neoadjuvant
anthracycline-based regimen.
- Determine the molecular predictors of lack of radiologic CR in HER-2/neu positive
patients (IHC 3+ or FISH amplified > 2. 0) after a neoadjuvant anthracycline-based
regime followed by a taxane alone regimen or in combination with trastuzumab.
- Determine the molecular predictors of complete magnetic resonance imaging radiologic
response to a neoadjuvant anthracycline-based regimen when gene expression profiling is
performed in a sequential, real-time fashion.
OUTLINE: This is a diagnostic, multicenter study conducted concurrently with
CALGB-150012/ACRIN-6657 imaging protocol and concurrently with neoadjuvant
anthracycline-based chemotherapy.
Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance
imaging (MRI) of the breast before initiation, 1-3 days after initiation, and then after
completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients
who previously received a taxane also undergo an additional contrast-enhanced MRI scan.
Patients undergo biopsies before initiation and at the time of surgery. Patients also
undergo blood draws at the time of the first biopsy and prior to surgery. Serum and tissue
samples are used to assess biomarkers of genetic instability, cell cycle progression and
cellular proliferation as predictors for anthracycline responsiveness, markers of apoptotic
potential as predictors for taxane responsiveness in vivo, angiogenesis, hormone receptors,
and molecular profiles using immunohistochemical methods.
Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before
surgery).
Patients are followed every 6 months for 5 years and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 384 patients will be accrued for this study within 3 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed adenocarcinoma of the breast by core needle
biopsy, incisional biopsy, or fine needle aspiration (FNA)
- Incisional biopsy must result in < 10% removal of gross residual disease
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
OR ≥ 10 mm by spiral CT scan OR
- Nonmeasurable disease
- Meets one of the following staging criteria:
- Stage II or III disease
- T4, any N, M0, including clinical or pathologic inflammatory disease
- Regional stage IV disease where supraclavicular/infraclavicular lymph nodes are
only site of metastasis
- No clinical or imaging evidence of distant metastasis
- Metaplastic carcinomas allowed
- Synchronous bilateral primaries allowed if the more advanced tumor meets staging
criteria
- Patients for whom FNA was used to confirm initial diagnosis must have histologically
confirmed invasive carcinoma by the start of chemotherapy
- Her-2/neu status known
- Currently receiving neoadjuvant chemotherapy consisting of a taxane-based regimen
alone or followed by an anthracycline-based regimen
- Concurrent enrollment in the ACRIN-6657/CALGB-150012 imaging protocol required
- Hormone receptor status:
- Any estrogen receptor or progesterone receptor status
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female Cardiovascular
- No uncontrolled or severe cardiovascular disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- No ferromagnetic prostheses including the following:
- Metallic implants not compatible with a magnetic resonance imaging machine
- Heart valves
- Aneurysm clips
- Orthopedic prosthesis
- Any metallic fragments anywhere in the body
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy to the ipsilateral breast for this malignancy
Endocrine therapy
- At least 4 weeks since prior tamoxifen or raloxifene
Radiotherapy
- No prior radiotherapy to the ipsilateral breast for this malignancy
Other
- No other prior cytotoxic regimens
Locations and Contacts
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Related publications: Carey LA, Oh D, Sawyer L, et al.: Gene expression subtype and p53 mutational status are correlated among neoadjuvantly treated breast cancers in UNC LCCC9819 and I-SPY1 (CALGB 150007/ACRIN 6657). [Abstract] J Clin Oncol 24 (Suppl 18): A-10048, 552s, 2006.
Starting date: February 2002
Last updated: July 23, 2015
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